Medical Play for Dental Anxiety

Overseen By Chaitanya P Puranik, BDS,MS,PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Frankl 3 or 4, Autism, others

Compensation: Varies

Number of Visits: 4

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Medical Play for Dental Anxiety?

Research shows that play therapy related to medical procedures can help reduce stress and anxiety in children, as seen in studies where children were more cooperative and less upset during hospital and surgical procedures after participating in related play sessions. Additionally, play behavior in a dental setting may help predict and manage dental anxiety, suggesting that incorporating play into dental care could help ease children's fears. ^{1 2 3 4 5}

Is medical play safe for children?

Research shows that therapeutic play, including medical play, is generally safe for children and can help reduce anxiety in medical settings. ^{3 4 5 6 7}

How is Medical Play different from other treatments for dental anxiety?

Medical Play is unique because it uses play activities to help children feel less anxious about dental procedures, unlike other treatments that might involve medication or counseling. This approach is based on the idea that engaging in play can make medical experiences less scary for kids, which has been shown to reduce anxiety in various medical settings. ^{2 4 5 7 8}

What is the purpose of this trial?

The purpose of this pilot study is to investigate the efficacy of medical play in the dental setting to improve the behaviors and cooperation of neurotypical patients during dental visits. The specific aims of the study are as follows: 1. To evaluate differences in behaviors and cooperation levels of subjects utilizing medical play before a routine dental exam visit in comparison to those undergoing a routine dental exam visit without use of medical play. 2. To evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit. 3. To evaluate provider perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 4. To evaluate caregiver perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 5. To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play. The hypotheses are as follows: 1. Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand. 2. Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand. 3. Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand. 4. Patients will report experiencing less anxiety, via the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f) after appointments in which medical play is utilized.

Research Team

Chaitanya P Puranik, BDS,MS,PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for neurotypical children aged 5-10 who have shown significant dental anxiety or aversion during past visits to the Children's Hospital Colorado Dental Center. They must be patients of record at this center and accompanied by their legal guardian.

Inclusion Criteria

Previously identified as Frankl 1 or Frankl 2 per the electronic dental record during dental exam visits (Epic)

My child is between 5 and 10 years old.

Child subject is neurotypical

Exclusion Criteria

My child is not between 5 to 10 years old.

Previously identified as Frankl 3 or Frankl 4 per the electronic dental record during dental exam visits (Epic)

Adult in attendance to dental visit with child is not the legal guardian

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants engage in either medical play or routine play before their dental exam visit

1 day

1 visit (in-person)

Dental Exam

Participants undergo a routine dental exam visit with or without medical play intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for behavior and cooperation improvements post-intervention

Immediately after dental visit

1 visit (in-person)

Treatment Details

Interventions

• Medical Play
• Routine Play

Trial Overview The study tests if 'medical play' before a dental exam can help improve cooperation and reduce anxiety in children, compared to routine play or no special preparation. It also assesses perceptions of behavior from providers, caregivers, and the patients themselves.

Participant Groups

Group I: Medical Play Intervention Active Control 1 Intervention

This group of participants will be engaged in medical play before the dental exam visit.

Group II: Routine Play Intervention Placebo Group 1 Intervention

This group of participants be engaged in routine play (coloring exercise) before the dental exam visit.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 45 children aged 3 to 4 years undergoing dental surgery, related play therapy significantly reduced stress and improved cooperation compared to unrelated play therapy and no preparation at all.

The related play therapy group showed less upset behavior during various stress points of the surgical process, indicating that preparing children with relevant play can effectively alleviate anxiety before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of psychological preparation on children hospitalized for dental operations. Schwartz, BH., Albino, JE., Tedesco, LA.[2019]

Therapeutic play significantly reduces anxiety levels in children aged 3-7 undergoing cast-removal procedures, with a mean difference of -20.1 compared to the control group.

Both parents and cast technicians reported higher satisfaction levels with the therapeutic play intervention, indicating its positive impact on the overall experience of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. Wong, CL., Ip, WY., Kwok, BMC., et al.[2019]

Children's behavior in dental settings can be predicted by their play behavior in a simulated environment, suggesting that play may be a reliable indicator of how they will act during dental visits.

Incorporating a play dental area in dental offices could help identify and manage potential problem patients, as it may desensitize them to aspects of dental treatment that cause anxiety, leading to better experiences during actual appointments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between children's dental behavior and play behavior. McTigue, DJ., Pinkham, J.[2009]

A study involving 50 children aged 5-10 years showed that participating in a group medical play session significantly reduced preoperative fear and anxiety, indicating its effectiveness as an intervention.

Facilitated by a Certified Child Life Specialist, the group medical play allowed children to explore medical equipment, which helped improve their coping skills and overall experience before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of the Relationship Between a Group Medical Play Intervention and Children's Preoperative Fear and Anxiety. Jones, MT., Kirkendall, M., Grissim, L., et al.[2021]

Therapeutic play has been shown to reduce anxiety and improve cooperative behavior in children undergoing invasive procedures, based on a systematic review of 12 studies conducted across various countries.

However, the overall evidence is considered questionable due to methodological issues in the studies, such as lack of randomization and blinding, indicating a need for more rigorously designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic play to prepare children for invasive procedures: a systematic review. Silva, RD., Austregésilo, SC., Ithamar, L., et al.[2022]

A 90-minute process drama workshop involving 63 children revealed that dental anxiety stems from fears related to the unknown, unpleasant sensory experiences, societal perceptions of dentists, and learned negative associations.

This innovative approach allows children to explore and express their feelings about dental anxiety, providing valuable insights that could inform pediatric dentistry and potentially other health-related fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inside the waiting room: process drama and dramatic distancing for involving children in research on dental anxiety. O'Grady, A., Gray-Burrows, K., Tahmassebi, J.[2022]

Therapeutic play was tested as a treatment for hospital-induced anxiety in children aged 5 to 11 over a four-year study in two hospital settings, showing promising results.

The study indicates that therapeutic play is an effective intervention for reducing anxiety in hospitalized children, highlighting its potential as a valuable therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic play: effects on hospitalized children. Clatworthy, S.[2004]

The study evaluated the effects of the Dramatic Therapeutic Play (DTP) technique on anxiety levels in 28 hospitalized school-age children, but found no significant difference in anxiety scores between the DTP group and the control group.

Despite the lack of significant results, the study suggests that further research with a larger sample size and varied hospitalization contexts is needed to better understand the potential benefits of DTP in reducing anxiety in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Silva, SGTD., Santos, MA., Floriano, CMF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of psychological preparation on children hospitalized for dental operations. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Association between children's dental behavior and play behavior. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Exploration of the Relationship Between a Group Medical Play Intervention and Children's Preoperative Fear and Anxiety. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Therapeutic play to prepare children for invasive procedures: a systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Inside the waiting room: process drama and dramatic distancing for involving children in research on dental anxiety. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Therapeutic play: effects on hospitalized children. [2004]

8. Brazil pubmed.ncbi.nlm.nih.gov

Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. [2022]